Tag Archives: Breyanzi

Breyanzi Included in the NCCN Guidelines for the Treatment of 2L DLBCL

On Tuesday, July 12, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-Cell Lymphomas were updated (NCCN Guidelines in B-Cell Lymphoma) to include Breyanzi’s (BMS’s CD19 CAR-T) treatment in 2L DLBCL. Of note, Breyanzi is now recommended as a 2L therapy for patients who have primary refractory disease or have relapsed within 12 months, as well as patients who are non-candidates for transplant. Below, Celltelligence provides insights on Breyanzi’s inclusion in the NCCN Guidelines, while discussing how Yescarta’s (Gilead / Kite’s CD19 CAR-T) NCCN recommendation.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated its CD19 CAR-T indications table for estimated US approvals and submissions following key Q1 2022 earnings presentations and recent press releases (see below for download).

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Thoughts on Breyanzi’s FDA Approval in 2L LBCL

On Friday, June 24, BMS announced (press release) that the FDA approved Breyanzi (CD19 CAR-T) in 2L LBCL. Of note, Breyanzi’s approval in 2L LBCL is based on results from the Ph3 TRANSFORM study and Ph2 PILOT trial. Below, Celltelligence provides insights on how Breyanzi’s broad label in 2L LBCL compares with key competitor Yescarta (Gilead / Kite’s CD19 CAR-T), while discussing how BMS may position Breyanzi in the 2L setting.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi Receives FDA Approval for 2L LBCL

Late on Friday, June 24, BMS announced (press release) that the FDA approved Breyanzi (CD19 CAR-T) in 2L LBCL based on results from the Ph3 TRANSFORM trial and Ph2 PILOT study. Of note, Breyanzi is the second CD19 CAR-T to move into an earlier line of therapy for LBCL. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi Could Receive a CHMP Opinion for 2L LBCL (TI) as Early as September 2022; Yescarta in 2L LBCL and Tecartus in R/R ALL Absent from June’s CHMP Highlights

On Friday, June 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed in June’s CHMP Highlights. Below, the Celltelligence team provides a full analysis of June’s CHMP meeting with updated EU timelines for Breyanzi in 2L LBCL (TI) and Tecartus in r/r ALL.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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The Race Continues in the 2L LBCL Setting; BMS and Gilead Provide Clinical Updates for Breyanzi and Yescarta; ASCO 2022 Analysis 1

ASCO 2022 Analysis 1: Gilead (Kite) and BMS presented clinical data updates in 2L LBCL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi’s Sales Increase While Abecma’s Remain Flat; BMS Prepares for an Increase in Cell Therapy Demand; No Clinical Milestone Updates for Breyanzi or Abecma; BMS’s Q1 2022 Earnings Call Summary

On Friday, April 29, BMS held their Q1 2022 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) revenue increase and anticipated US approval in 2L LBCL. Of note, no updated clinical milestones for Breyanzi and Abecma (BCMA CAR-T) were observed. Below, Celltelligence provides insights on how Breyanzi’s revenue increase compares with Kymriah (Novartis’s CD19 CAR-T) and Yescarta (Gilead/Kite’s CD19 CAR-T).

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Thoughts on Breyanzi’s sNDA Acceptance in Japan for 2L LBCL

BMS recently announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) accepted Breyanzi’s (CD19 CAR-T) sNDA in 2L LBCL. Below, Celltelligence provides insights on Breyanzi’s potential approval timeline for 2L LBCL in Japan, while discussing possible reimbursement issues as the CD19 CAR-T moves into earlier lines of therapy.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi’s sNDA Accepted in Japan for 2L DLBCL

On Friday, March 25, BMS announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted Breyanzi’s (CD19 CAR-T) sNDA for 2L DLBCL. Of note, the acceptance is based on results from Breyanzi’s Ph3 TRANSFORM trial. The Celltelligence team will be conducting a full thoughts-on analysis and provide potential approval timelines in the coming days.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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BMS Receives Priority Review for Breyanzi in 2L LBCL; Breyanzi’s PDUFA Date Set for June 24, 2022

On Thursday, February 17, BMS announced (press release) that the FDA has granted a Priority Review for Breyanzi (CD19 CAR-T) in 2L LBCL, with a PDUFA date of June 24, 2022. Below, Celltelligence provides additional thoughts on how Breyanzi’s anticipated US approval in the 2L setting compares with Yescarta (Gilead / Kite; CD19 CAR-T).

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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